Associate Director, Regulatory Affairs

MISSION

Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously.

POSITION SUMMARY

The Associate Director, Global Regulatory Affairs provides management of all aspects of assigned regulatory activities related to the development and commercialization of novel drugs including quality, nonclinical and clinical areas of drug development. This position will manage the timely delivery of regulatory applications by working with internal stakeholders and with corporate partners and distributors, as applicable, across multiple countries. The role is responsible for ensuring regulatory compliance and overseeing submissions and approvals of regulatory procedures including but not limited to IND, NDA, MAA, and life cycle management activities.

JOB FUNCTIONS/RESPONSIBILITIES

• Develops and leads the regulatory strategy for assigned projects under the supervision of regulatory management.
• Leads the Global Regulatory Project Team Meetings in collaboration with Regulatory Project Management, as applicable. May also be representing the regulatory function in the Program Team, as required.
• Leads the preparation of regulatory documentation (meeting request/briefing books) in support of interactions with Health Authorities.
• Support the Clinical Operation Team with Clinical Trial Applications, as applicable.
• Leads the preparation and the critical review of submission documents to ensure compliance with regulatory requirements.
• Contributes to and reviews responses to global Health Authority’s questions to ensure appropriate, consistent, and complete responses, ensuring their alignment with global development strategy.
• Establishes and maintains excellent relationships with international partners and distributors.
• Provide global regulatory advice through the product life cycle via active participation in the Global Regulatory Project Team (e.g., develop international regulatory strategies in collaboration with other regulatory members assigned to the project, timeline development, change control and preparation of submission related documents) for the assigned project.
• In partnership with Regulatory Project Management, Regulatory Labelling and Regulatory CMC, oversees the development of content and format for regulatory submissions and related variations/amendments internationally.
• Actively participates in Health Authority meetings.

QUALIFICATIONS

• Bachelor’s or Master’s degree in biological or life sciences or related scientific discipline, pharmacy or medicine (or international equivalent); An advanced degree is desirable.
• A minimum of 10 years in the pharmaceutical industry with a minimum of 8 years in Global Regulatory Affairs, experience with major Health Authority (US FDA, Health Canada, and EMA) is mandatory.
• Strong understanding of US FDA, EU and international pharmaceutical guidance, regulations, drug development process, and industry standard practices.
• Experience with Health Authority negotiations.
• Experience with major regulatory submissions (e.g. New Drug Applications (NDA/NDS/MAA), post marketing activities, Paediatric Investigation Plans (PIP) and Orphan Drug Designation (ODD) activities) is highly preferred.
• Experience in all phases of clinical development is preferred.
• Demonstrated ability to analyze and interpret efficacy and safety data.
• Strong understanding of regulatory operational activities.
• Outstanding management, interpersonal, communication, negotiation, and problem-solving skills.
• Demonstrated proficiency in organizational awareness, including experience working cross-functionally and on global teams.

Work Environment:

• This is a high-growth, fast-paced small organization. The ability to be productive and a team player is critical.
• Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be 10-15% of work time.
• On site presence at the headquarter is required (minimum 2 days a week).

The salary range for this position is $210,000 to $225,000 USD. Compensation will be determined based on several factors including, but not limited to; skill set, years of experience, and the employee’s geographic location. Please note that the required compensation details listed in US role postings reflect the base salary only, and do not include bonus, equity, or benefits unless otherwise provided.

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Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran’s status or any other classification protected by applicable State/Federal/Local laws.

Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.